Project Compliance Officer

Preventx; Sheffield; On-site; GBP 40,000 - 56,000; Full time

Job summary

Preventx is seeking a Project Compliance Officer to validate laboratory analysers, assays, and operations systems, ensuring compliance with ISO 15189, ISO 27001, ISO 9001, ISO 14001, and Medical Device regulations. The role is based at Head Office, Meadowhall, Sheffield, with an application closing date of 30 September 2026.

The post holder will support the Operations and Quality teams to maintain compliance and oversee validation activities across the laboratory network.

Qualifications

• Experience with ISO 15189/ISO 27001/ISO 9001/ISO 14001 and medical device regulatory frameworks.
• Strong analytical mindset with attention to detail and accuracy.
• Ability to perform validation and verification in a regulated lab environment.

Responsibilities

• Plan, write, and execute validation/verification protocols for new analysers, assays, and laboratory systems.
• Conduct validation studies: accuracy, precision, linearity, detection limits, measurement uncertainty, and reference interval verification.
• Document validation activities to meet ISO 15189 and internal QMS requirements.
• Lead IQ/OQ/PQ processes for equipment and software.
• Support operations to maintain ongoing accreditation compliance.
• Maintain validation records and equipment files per accreditation requirements.
• Participate in internal audits, external assessments, and CAPA processes.
• Support competency assessments and training related to new instruments and assays.
• Contribute to compliance efforts across ISO 27001, ISO 9001, and ISO 14001.

Job description

JOB DESCRIPTION

Project Compliance Officer

Responsible to: Head of Laboratory Operations

Key Relationships

Quality, Warehouse and Clinical teams, Program manager

Purpose of Role

Responsible for validating new laboratory analysers, assays, and operations systems while ensuring compliance with ISO 15189, ISO 27001, ISO 9001, ISO 14001, and Medical Device regulations to support safe, secure, high-quality operations

Location

Head Office, Preventx Ltd, MBP5, Meadowhall Business Park, Carbrook Hall Road, Sheffield S9 2EQ

Application closing date: 30 September 2026

About Preventx

Preventx is a fast-growing technology company with more than 13 years’ experience as the market leader in online sexual health and STI sampling services. We work with over 60 local authority regions and NHS providers across the UK and are a trusted partner of the NHS. Our services have enabled around 1.7m people to test for STIs, improving public health whilst saving money. With recent investment, the company is committed to growth and continuous improvement. You will join a supportive team where you’ll be encouraged to do your best work and define the way we use data in the business.

This role ensures that all validation and change activities meet regulatory, accreditation, and manufacturer requirements. The post holder supports the Operations and Quality teams in maintaining compliance with ISO 15189, ISO 27001, ISO 9001, ISO 14001, and Medical Device regulatory frameworks, ensuring safe, secure, and high‑quality laboratory services

Key Responsibilities

• Plan, write, and execute validation and verification protocols for new analysers, assays, methodologies, and laboratory systems.
• Perform validation studies including accuracy, precision, linearity, detection limits, measurement uncertainty, and reference interval verification.
• Document all validation activities to meet ISO 15189 and internal QMS requirements.
• Lead IQ/OQ/PQ processes for new equipment and software.
• Support operational teams to ensure continuous compliance with accreditation standards.
• Maintain documentation, validation records, and equipment files in line with accreditation requirements.
• Participate in internal audits, external assessments, and CAPA processes.
• Support competency assessments and training related to new instruments and assays.
• Contribute to compliance efforts across ISO 27001 (information security), ISO 9001 (quality management), and ISO